Effect of VR-MBCT in Chronic Nonspecific Low Back Pain

Chronic nonspecific low back pain (CNLBP) is a leading global cause of disability, yet conventional treatments often focus on structural damage and neglect cognitive, emotional, and behavioral dimensions. Mindfulness-based cognitive therapy (MBCT) is effective for chronic pain but limited by therapist resources and low adherence. Virtual reality (VR) provides an immersive, standardized platform to improve treatment fidelity, engagement, and scalability. This multi-center randomized controlled trial investigates a tailored 8-week VR-MBCT intervention for CNLBP. The intervention group receives a hybrid VR-MBCT program consisting of 1 weekly in-clinic VR session (approximately 30 minutes) plus at least 3 home-based audio practice sessions (20-30 minutes per session) for 8 weeks. The progressive curriculum includes automatic pilot and awareness, body scan, mindful movement, graded exposure, responding versus reacting, cognitive defusion, self-compassion, relapse prevention, self-care, and real-world transfer training. The control group receives usual medical care only during the 8-week study period and will be offered the same VR-MBCT intervention after completing the 26-week follow-up. Outcome assessments are conducted at baseline (T0), week 4 (T1), week 8 (T2), and week 26 (T3). Co-primary outcomes are the proportion of participants achieving ≥30% improvement in Oswestry Disability Index (ODI) and back pain bothersomeness (0-10 scale) at week 8. Secondary outcomes include pain intensity (NRS), global improvement, depression (PHQ-9), anxiety (GAD-7), physical activity (IPAQ-SF), sleep quality (SQS), fear-avoidance beliefs (FABQ-PA), pain catastrophizing (PCS), work productivity and activity impairment (WPAI-GH), and use of concomitant treatments. System usability scale (SUS) and patient satisfaction are assessed in the intervention group only. Safety assessments include monitoring and grading of VR-related adverse events such as dizziness, nausea, eye fatigue, headache, and falls at each contact. Randomization is performed using a computer-generated sequence with 1:1 allocation, stratified by sex and pain duration (\<2 years versus ≥2 years). Outcome assessors and statisticians are blinded to group assignment. Data management follows Good Clinical Practice (GCP) with double-entry verification and independent monitoring. This study will provide evidence for VR-MBCT as a scalable, standardized, non-pharmacological adjunctive intervention for CNLBP.